Development, Validation and Clinical Efficacy Evaluation of an AI-based Snake Species Identification System for Snakebite Treatment: a Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Snake species identification (64-class classification) and venomous/non-venomous snake discrimination (binary classification)
研究概览
简要总结
This multicenter prospective observational study aims to develop and validate a deep learning-based artificial intelligence snake species identification system, and evaluate its clinical application efficacy in real-world emergency snakebite treatment scenarios. The primary research question it seeks to answer is:
In real clinical settings in Zhejiang Province, can the artificial intelligence snake species identification system accurately identify common indigenous snake species causing bites, and improve the accuracy and diagnostic efficiency of snake species judgment for physicians at different levels of medical institutions? This study will be conducted simultaneously in 10 medical institutions in Zhejiang Province. investigators will prospectively enroll patients with snakebite who present to the hospital between June 2026 and December 2026 and can provide photographs of the offending snakes. The snake species identification results of both attending physicians and the artificial intelligence system will be recorded synchronously, and the patients' clinical treatment and prognosis data will be collected. All patients will be followed up until 30 days after discharge.
详细描述
2. Methods 2.1 Study Design and Subjects This is a multicenter, phased model development and validation study conducted from May 15, 2025 to December 31, 2026 (corrected from the original typo "2006"). The study is implemented in 4 phases. This study was approved by the Institutional Review Board for Human Research, the Second Affiliated Hospital, Zhejiang University School of Medicine (Approval No.: (2026) Lun Shen Yan No. 0789). Informed consent was obtained from all patients in accordance with the Declaration of Helsinki.
2.2 Datasets
- Retrospective Dataset (Phases 1-2) Images were obtained from three sources: ① Public databases (https://www.inaturalist.org/home) and snake field guides; ② Photographs of offending snakes provided by patients or witnesses and collected by attending physicians in the Emergency Departments of 42 hospitals in Zhejiang Province from January 2021 to June 2026.
After strict screening, a total of 15,680 images were finally included. The dataset was divided into three independent subsets (training set, validation set, and test set) at a ratio of 7:2:1 using stratified random sampling.
Image Inclusion and Exclusion Criteria Inclusion criteria: Images clearly showing at least one key identifying feature of the snake body (head shape, scale texture, body color and pattern, tail characteristics, etc.); covering common clinical scenarios (grassland, rocks, farmland, indoor, clinical settings), shooting conditions (natural light, night lighting, low light on rainy days), shooting angles (front, side, back, close-up), and snake states (stationary, slight motion blur, partial occlusion); image resolution ≥ 1080×1920 pixels with no obvious post-processing traces.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged ≥18 years, regardless of gender
- •Definite history of snake bite, with time from bite occurrence to first medical visit ≤24 hours
- •The patient or eyewitness can provide digital images of the biting snake (taken by mobile phone, camera, etc.)
- •Voluntarily sign the written informed consent form; for patients with impaired consciousness who cannot sign independently, their legal representative shall sign on their behalf, and a secondary confirmation shall be obtained after the patient regains consciousness
- •Able to cooperate in completing follow-up assessments at discharge and 30 days after injury
排除标准
- •1. Unable to provide snake images, or images are severely blurred resulting in complete loss of key identification features
- •Snake species cannot be confirmed by the gold standard (no eyewitnesses, no typical clinical manifestations, cannot be clarified by expert panel consultation)
- •Medical visit exceeds 24 hours and the exact bite time and initial clinical manifestations cannot be determined
- •Complicated with end-stage malignant tumors, severe liver and kidney failure, or other underlying diseases that may significantly affect prognosis judgment
- •Refuse to sign the informed consent form or cannot cooperate in completing follow-up
- •Simultaneously participating in other clinical studies that may affect the results of this study
结局指标
主要结局
Snake species identification (64-class classification) and venomous/non-venomous snake discrimination (binary classification)
时间窗: From enrollment to the end of treatment at 30 days
次要结局
- Consistency between physicians' judgments and AI results(%)(From enrollment to the end of treatment at 30 days)
- median time from hospital presentation to definitive snake species identification(hour)(72 hours)